Long-term safety of KarXT in adults with bipolar I mania
Studies the long-term safety of KarXT in adults with bipolar I mania.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Key facts
- Where
- Anaheim, Atlanta, Austin, Bellflower, Bentonville, Boynton Beach, Carrollton, Cerritos, Charlotte, Chicago, Chino, Cincinnati, Culver City, Decatur, DeSoto, Flowood, Gaithersburg, Garden Grove, Glendale, Hallandale, Hialeah Gardens, Hollywood, Houston, Indianapolis, Irving, La Habra, Lincoln, Little Rock, Mansfield, Marlton, Miami, Miami Lakes, Miami Springs, Montclair, New Haven, North Canton, North Las Vegas, Northridge, Orange, Richardson, Riverside, Rogers, Santa Ana, Savannah, Scottsdale, St Louis, St. Petersburg, Staten Island, Torrance, Tucson, West Chester, and Wichita Falls, United StatesSee the 61 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06929273, who can take part
Where in United States
- Advanced Research Center, Inc.Anaheim, United StatesTaking people
- Atlanta Center for Medical ResearchAtlanta, United StatesTaking people
- Synexus Clinical Research US IncAtlanta, United StatesTaking people
- Community Clinical ResearchAustin, United StatesTaking people
- Clinical Innovations, Inc. dba CITrialsBellflower, United StatesTaking people
- Pillar Clinical Research - RichardsonBentonville, United StatesTaking people
- Health Synergy Clinical ResearchBoynton Beach, United StatesTaking people
- CarrolltonCarrollton, United StatesNot yet recruiting
- CerritosCerritos, United StatesNot yet recruiting
- CerritosCerritos, United StatesNot yet recruiting
- CharlotteCharlotte, United StatesNo longer taking part
- ChicagoChicago, United StatesNot yet recruiting
- Pillar Clinical Research -ChicagoChicago, United StatesTaking people
- Inland Psychiatric Medical Group - ChinoChino, United StatesTaking people
- University of Cincinnati Medical CenterCincinnati, United StatesTaking people
- ProScience Research GroupCulver City, United StatesTaking people
- CenExel iResearch, LLCDecatur, United StatesTaking people
- Adams Clinical DallasDeSoto, United StatesTaking people
- Precise Research CentersFlowood, United StatesTaking people
- CBH HealthGaithersburg, United StatesTaking people
- Collaborative NeuroScience Research , LLCGarden Grove, United StatesTaking people
- GlendaleGlendale, United StatesNot yet recruiting
- Velocity Clinical Research, Hallandale BeachHallandale, United StatesTaking people
- Hialeah GardensHialeah Gardens, United StatesNot yet recruiting
- Behavioral Clinical ResearchHollywood, United StatesTaking people
- Research Centers of America (Hollywood)Hollywood, United StatesTaking people
- Elevate Clinical Research - HoustonHouston, United StatesTaking people
- HoustonHouston, United StatesNo longer taking part
- IndianapolisIndianapolis, United StatesNot yet recruiting
- IrvingIrving, United StatesNo longer taking part
- Omega Clinical Trials - La HabraLa Habra, United StatesTaking people
- LincolnLincoln, United StatesNot yet recruiting
- Pillar Clinical Research - Little RockLittle Rock, United StatesTaking people
- Woodland International Research GroupLittle Rock, United StatesTaking people
- Prime Clinical Research - MansfieldMansfield, United StatesTaking people
- Hassman Research Institute Marlton SiteMarlton, United StatesTaking people
- MarltonMarlton, United StatesNo longer taking part
- Advanced Research Institute of MiamiMiami, United StatesTaking people
- LCC Medical Research InstituteMiami, United StatesTaking people
- Innovative Clinical Research, Inc.Miami Lakes, United StatesTaking people
- South Florida Research Phase I - IVMiami Springs, United StatesTaking people
- Catalina Research Institute, LLCMontclair, United StatesTaking people
- Yale New Haven Hospital-Smilow Cancer CenterNew Haven, United StatesTaking people
- Neuro-Behavioral Clinical ResearchNorth Canton, United StatesTaking people
- North Las VegasNorth Las Vegas, United StatesNot yet recruiting
- North Las VegasNorth Las Vegas, United StatesNo longer taking part
- NorthridgeNorthridge, United StatesNot yet recruiting
- NRC Research InstituteOrange, United StatesTaking people
- Pillar Clinical Research - RichardsonRichardson, United StatesTaking people
- Clinical Innovations, Inc. dba CITrialsRiverside, United StatesTaking people
- Woodland Research NorthwestRogers, United StatesTaking people
- Santa AnaSanta Ana, United StatesNo longer taking part
- CenExel iResearch, LLCSavannah, United StatesTaking people
- ScottsdaleScottsdale, United StatesNot yet recruiting
- Arch Clinical TrialsSt Louis, United StatesTaking people
- St. PetersburgSt. Petersburg, United StatesNot yet recruiting
- Richmond Behavioral AssociatesStaten Island, United StatesTaking people
- Collaborative Neuroscience Research LLCTorrance, United StatesTaking people
- TucsonTucson, United StatesNot yet recruiting
- West ChesterWest Chester, United StatesNot yet recruiting
- Wichita FallsWichita Falls, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06929273EU 2024-520259-26-00
- Record updated
- 26 October 2026
- Original description
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)Read full original descriptionShow less
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)
The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
Inclusion: Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):; Participants must have completed treatment period of parent study; De novo participants who did not participate in double-blind placebo-controlled studies:; Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania; Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline; Participants must have CGI-BP score of ≥ 3 at Screening and at baseline; Participants does not require hospitalization for acute mania.
Exclusion: De novo participants who did not participate in double-blind placebo-controlled studies:; Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year); Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders; Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test; Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months; Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma; All participants:; All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS; Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):; Discontinuation from any KarXT parent studies; Other protocol-defined Inclusion/Exclusion criteria apply.